Analytical Development Expert (all genders) - limited for 2 years (part-time possible)
Merck
Darmstadt, Germany
vor 3 Tg.

A career at our company is an ongoing journey of discovery : our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics.

For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility.

Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life.

Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

Your role :

You take over project responsibility as analytical development expert in CMC teams for new chemical entities (NCE) and antibody-drug-conjugates (ADC) from preclinical phase, throughout clinical development until commercialization and subsequent lifecycle management.

You work in a GMP environment, assess the quality of drug substance and drug product intended for use in clinical trials and act as Head of Quality Control according to German and EU legislation.

You define the analytical strategy and contribute to the achievement of the CMC-Team by influencing strategic decisions.

You solve complex or novel problems by thorough and logical investigations and scientific principles. Consequently, you take risk-based decisions and develop innovative solutions.

Furthermore, you develop quality relevant specifications for drug substances and products and its precursors, you are responsible for structure elucidation of impurities, setup, monitoring and evaluation of (accelerated) stability studies.

You coordinate and drive the scientific strategy for analytical method development of new drug substances and drug products.

This includes scientifically sound development and application of (hyphenated) separation- and identification techniques in-house or with interface partners.

During the product design phase, you assure a comprehensive understanding of the chemical and physical nature of the individual active substance(s) and excipients, and of the way their attributes interact in the formulation and how they are impacted by the manufacturing process.

You co-operate within interdisciplinary and international teams, especially with other functions of Chemical and Pharmaceutical Development and Global Pharma Operations.

You collaborate closely with contract development & manufacturing organizations (CDMOs), you evaluate their capabilities, and you are accountable for managing them.

You review and contribute to CMC-related regulatory documents intended for submission to Health Authorities. You ensure launch readiness for all analytical activities including the transfer of methods to commercial organizations following Quality-by-Design principles overseeing the Process Performance Qualification activities.

Finally, you serve as best practice resource within the department of Analytical Development.

Who you are :

  • Master of Science or equivalent in Natural Sciences, Pharmacy, Chemistry or similar, preferably Ph.D., with a strong emphasis on analytical science
  • Profound knowledge of analytical technologies including separation and identification methods with focus on NCE development
  • 3+ years of experience in the pharmaceutical industry in similar position
  • Deep knowledge of current quality and regulatory requirements relevant for NCE development in the ICH region
  • Very good communication skills, both written and oral in German and English
  • Excellent organizational skills, reliable team player
  • Highly motivated and result-oriented, willingness to take on responsibility and going the extra mile
  • What we offer : With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons.

    We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life.

    Join us and bring your curiosity to life!

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